Job description

Yacht Life Sciences has a vacancy for an Associate Scientist to work for Janssen Vaccines / Johnson & Johnson (Leiden, the Netherlands), within Drug substance operation (DSO).

Purpose of the Job:

• Execution and documentation of CTM production according to planning and GMP regulations.
• Interpretation of the results and reporting.
• Conclude on results in consultation with the associate scientist contributing to the improved set-up of the batches produced within DSO or leading to improved execution of these batches.
• Perform additional tasks for the operating of the department, e.g. project lead in projects for continuous improvement and guiding the operational team in GMP and PE tools.

Working relationships and contacts:

In this role you will direct reporting line to Supervisor, connect with warehouse, interacts with stakeholders and customer at Operations and QA, connect with the P, I and D team and with LS, USP and DSP.

Principal responsibilities:

1. Taking part in all activities related to the production of cGMP batches. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.

2. Ensures accurately completion of documentation such as batch records, logbooks, etc.

3. Working precisely, detecting and solving acute problems and communicate possible abnormalities.

4. Provides solutions to problems of moderate scope of complexity and exercises judgment within generally defined policies and procedures to determine appropriate action

5. Preparing, assemble and disassembly of process equipment for production activities.

6. Write and updating protocols, test methods, standard operating procedures and batch documentation.

7. Works as directed within documentation

8. Collects, analyzes, and compiles data. Summarizes data for interpretation by supervisor

9. Practical realization of the development (experiments and tests) under the supervision of scientist(s) and in line with procedures (GLP, SOP, LSN –laboratory solution number-, LSS –laboratory solution sheet)

10. Operates and maintains laboratory equipment; operates hands-on analytical and other instruments considered standard in their area of expertise

11. Internal organization of the lab, including safety,5s and housekeeping procedures

12. Implementation of new techniques

13. Actively participating in setting up documentation to ensure successful production runs.

14. Responsible to assist supervisor that the production areas are according EHSS and compliance standards.

15. Deviation investigation and follow up.

16. Write documentation and perform training of new operators.

17. Use process excellence activities to continuously improve the work as well as personal skills.

18. Guide department and operational team in use of PE tools as well as GMP

19. Act as SME and project lead

20. Replace supervisor during absence